Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor

Completed · Phase 2

Conditions studied: Gastrointestinal Stromal Tumor

In brief

Phase II trial to study the effectiveness of neoadjuvant and adjuvant imatinib mesylate in treating patients who are undergoing surgery for primary or recurrent malignant gastrointestinal stromal tumor. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving imatinib mesylate before and after surgery may shrink the tumor so it can be removed and may kill any tumor cells remaining after surgery.

Key facts

Study ID

NCT00028002

Run by

National Cancer Institute (NCI)

People needed

63

Starts

2002-03-31

Expected to finish

2009-01-28

Last updated by the study team

2020-10-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed malignant gastrointestinal stromal tumor
• Potentially resectable primary disease
• Potentially resectable recurrent disease
• Local or intra-abdominal/pelvic metastatic disease
• Documented c-kit (CD117) expression by immunohistochemical analysis of either initial core specimen or, if recurrent disease, from original tumor block
• Primary disease must be visceral, intra-abdominal, or pelvic in origin
• At least 1 unidimensionally measurable lesion
• At least 5 cm for primary disease
• At least 2 cm for recurrent disease
• At least 1 viable core biopsy tumor specimen obtained within 8 weeks before registration
• Performance status - Zubrod 0-2
• WBC at least 3,000/mm\^3
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• ALT/AST no greater than 2.5 times ULN
• No uncontrolled chronic liver disease
• Creatinine no greater than 1.5 times ULN
• No uncontrolled chronic renal disease
• No New York Heart Association class III or IV cardiac disease
• Must be able to lie still in the PET scanner for approximately 1-2 hours
• No uncontrollable hyperglycemia
• No medical or psychological condition that would preclude study participation
• No severe or uncontrolled medical disease
• No active uncontrolled infection

Where it is running

• Radiation Therapy Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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